Two-Year Outcomes of Phacogoniotomy vs Phacotrabeculectomy for Advanced Primary Angle-Closure Glaucoma With Cataract: A Noninferiority Randomized Clinical Trial
Importance Intraocular pressure (IOP) reduction with phacogoniotomy (phacoemulsification plus goniosynechialysis plus goniotomy) was not less than that of phacotrabeculectomy for advanced primary angle-closure glaucoma (PACG) with cataract at 1-year follow-up, but longer-term outcomes are needed. Objective To investigate if phacogoniotomy is noninferior to phacotrabeculectomy for advanced PACG with cataract at 2 years. Design, Setting, and Participants This multicenter, noninferiority, randomized clinical trial took place in 7 ophthalmology centers in China. The trial started May 31, 2021, and 2-year follow-up ended May 31, 2024. Included in this analysis were patients with advanced PACG and cataract. Study data were analyzed from September 2024 to January 2025. Interventions Random assignment (1:1) to phacogoniotomy or phacotrabeculectomy. Main Outcomes and Measures The primary outcome measure was reduction in IOP from baseline to the 2-year visit with a noninferiority margin of 4 mm Hg. Results A total of 124 participants (124 eyes) were randomized (mean [SD] age, 66.4 [8.6] years; 67 female [54.0%]), 65 (52.4%) to the phacogoniotomy group and 59 (47.6%) to the phacotrabeculectomy group. A total of 59 patients (90.7%) in the phacogoniotomy group and 52 patients (88.1%) in the phacotrabeculectomy group completed 2-year visits. All participants were Chinese. Mean (SD) IOP reduction was -25.6 (10.2) mm Hg and -24.7 (9.4) mm Hg in the phacogoniotomy and phacotrabeculectomy groups, respectively, and the upper boundary of the CI for difference in change between groups was lower than the 4-mm Hg noninferiority margin (mean difference, -0.5 mm Hg; 97.5% CI, -1.7 mm Hg to 0.8 mm Hg; P = .42). The mean difference for complete success for phacogoniotomy vs phacotrabeculectomy was -6.7% (95% CI, -21.4% to 8.8%; P = .47) and for qualified success was 1.4% (95% CI, -11.0% to 14.3%, P = .30). Median (IQR) number of antiglaucomatous medication was 0 (0) vs 0 (0; Hodges-Lehmann estimate of location shift, 0; 95% CI, 0; P =.12) with phacogoniotomy vs phacotrabeculectomy, respectively (mean difference, 0.13; 95% CI, -0.36 to 0.63; P = .60). Conclusions and Relevance Mean IOP reduction with phacogoniotomy was noninferior to phacotrabeculectomy for advanced PACG and cataract at 2-year follow-up with no differences detected in complete or qualified success or mean number of antiglaucomatous medications. These findings support phacogoniotomy as an alternative to phacotrabeculectomy for patients with advanced PACG and cataract.
基金:
National Key Research and Development Program of China (grant number:2022YFC2502800); National Natural Science Foundation of China (No. 82401251); the China Postdoctoral Science Foundation (2023M744052);the Science and Technology Program of Guangzhou, China (grant number:2024A03J0250); Medical application technology tracking project in Hebei Province (project number:GZ2022094); Chongqing Natural Research
Foundation (No: CSTB2022NSCQ-MSX0077); Fujian provincial health technology project (2022-CXA-016).
第一作者机构:[1]Sun Yat Sen Univ, Guangdong Prov Clin Res Ctr Ocular Dis, Guangdong Prov Key Lab Ophthalmol & Visual Sci, State Key Lab Ophthalmol,Zhongshan Ophthalm Ctr, Guangzhou, Peoples R China
共同第一作者:
通讯作者:
通讯机构:[1]Sun Yat Sen Univ, Guangdong Prov Clin Res Ctr Ocular Dis, Guangdong Prov Key Lab Ophthalmol & Visual Sci, State Key Lab Ophthalmol,Zhongshan Ophthalm Ctr, Guangzhou, Peoples R China[*1]Sun Yat Sen Univ, Zhongshan Ophthalm Ctr, State Key Lab Ophthalmol, 7 Jinsui Rd, Guangzhou 510060, Peoples R China
推荐引用方式(GB/T 7714):
Song Yunhe,Fan Sujie,Tang Li,et al.Two-Year Outcomes of Phacogoniotomy vs Phacotrabeculectomy for Advanced Primary Angle-Closure Glaucoma With Cataract: A Noninferiority Randomized Clinical Trial[J].JAMA OPHTHALMOLOGY.2025,143(6):462-469.doi:10.1001/jamaophthalmol.2025.0685.
APA:
Song, Yunhe,Fan, Sujie,Tang, Li,Lin, Fengbin,Li, Fei...&Zhang, Xiulan.(2025).Two-Year Outcomes of Phacogoniotomy vs Phacotrabeculectomy for Advanced Primary Angle-Closure Glaucoma With Cataract: A Noninferiority Randomized Clinical Trial.JAMA OPHTHALMOLOGY,143,(6)
MLA:
Song, Yunhe,et al."Two-Year Outcomes of Phacogoniotomy vs Phacotrabeculectomy for Advanced Primary Angle-Closure Glaucoma With Cataract: A Noninferiority Randomized Clinical Trial".JAMA OPHTHALMOLOGY 143..6(2025):462-469